Cleared Traditional

K984106 - MAMMARY SIZER, MAMMARY PROTHESIS SIZER

K984106 · Specialty Surgical Products, Inc. · General & Plastic Surgery device
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Feb 1999
Decision
87d
Days
-
Risk

K984106 is an FDA 510(k) clearance for the MAMMARY SIZER, MAMMARY PROTHESIS SIZER. Classified as Mammary Sizer (product code MRD).

Submitted by Specialty Surgical Products, Inc. (Hamilton, US). The FDA issued a Cleared decision on February 12, 1999 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Specialty Surgical Products, Inc. devices

FDA 510(k) Submission Details - K984106

510(k) Number K984106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1998
Decision Date February 12, 1999
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

MRD Device Classification - Class 0,

Product Code MRD Mammary Sizer
Device Class -

Regulatory Peers - MRD Mammary Sizer

All 11
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